← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

HWC — Screw, Fixation, Bone

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3040
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
31
510(K)/PMA CLEARANCES
510k: 31
0
RECALL ENTRIES

Recent clearances

K260809Arthrex, Inc. · 510k2026-06-25
K253108Steps Ortho · 510k2026-06-05
K261154In2Bones USA, LLC · 510k2026-05-30
K261241TriMed, Inc. · 510k2026-05-14
K254215Arthrex, Inc. · 510k2026-05-08
K254077OSSIO , Ltd. · 510k2026-05-01
K260934Medartis AG · 510k2026-04-17
K252699University of Utah, Department of Orthopaedics · 510k2026-04-10

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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